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Hologic Faxitron Core Specimen Radiography System - HSA Registration DE0014634

Access comprehensive regulatory information for Hologic Faxitron Core Specimen Radiography System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0014634 and owned by Hologic Inc.. The device was registered on January 16, 2014.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0014634
Hologic Faxitron Core Specimen Radiography System
HSA Registration Number: DE0014634
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Product Description

The CoreVision Digital Specimen Radiography (DSR) System is a compact desktop cabinet digital X-ray imaging system intended to provide rapid verification of core biopsies.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0014634
Registration Date
January 16, 2014
Change Notification Approval Date
December 12, 2024
Retention Due Date
January 15, 2026
Product Owner
Short Name
Hologic Inc.
Address
600 Technology Drive, Newark, DE 19702, UNITED STATES
Registrant
Address
219 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #08-02, SINGAPORE 159556
Importer
Address
3006 UBI ROAD 1, KAMPONG UBI INDUSTRIAL ESTATE, #02-336, SINGAPORE 408700
Model Information
Model Name(s)
Faxitron Core Tray (Pack of 25) Faxitron Core Digital Specimen Radiography System
Model Identifier(s)
04-4126 COREVISION5X10